title: Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial.
abstract: This trial evaluated the feasibility and efficacy of the infusion of mesenchymal stem cells expanded using human serum for the treatment of refractory acute or chronic graft-versus-host disease. Twenty-eight expansions were started. In 22, a minimum of more than 1 x 10⁶ mesenchymal stem cells/kg were obtained after a median of 26 days; this threshold was not obtained in the remaining cases. Ten patients received cells for the treatment of refractory or relapsed acute graft-versus-host disease and 8 for chronic disease. One patient treated for acute graft-versus-host disease obtained a complete response, 6 had a partial response and 3 did not respond. One of the chronic patients achieved complete remision, 3 a partial response, and 4 did not respond. The current study supports the use of this approach in less heavily treated patients for both acute and chronic graft-versus-host disease. The trial has been registered at ClinicalTrials.gov: identifier NCT00447460.
authors.affiliation: Servicio de Hematología, Instituto de Biomedicina de Sevilla (IBIS) Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Avenida Manuel Siurot s/n 41013 Sevilla, Spain. josea.perez.simon.sspa@juntadeandalucia.es
authors.forename: Jose A
authors.initials: JA
authors.lastname: Pérez-Simon
authors.forename: Olga
authors.initials: O
authors.lastname: López-Villar
authors.forename: Enrique J
authors.initials: EJ
authors.lastname: Andreu
authors.forename: José
authors.initials: J
authors.lastname: Rifón
authors.forename: Sandra
authors.initials: S
authors.lastname: Muntion
authors.forename: María
authors.initials: M
authors.lastname: Diez Campelo
authors.forename: Fermín M
authors.initials: FM
authors.lastname: Sánchez-Guijo
authors.forename: Carmen
authors.initials: C
authors.lastname: Martinez
authors.forename: David
authors.initials: D
authors.lastname: Valcarcel
authors.forename: Consuelo Del
authors.initials: CD
authors.lastname: Cañizo
mesh_terms: D000328:Adult; D000368:Aged; D049109:Cell Proliferation; D002478:Cells, Cultured; D046508:Culture Techniques; D005260:Female; D006086:Graft vs Host Disease / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000378:metabolism; D008875:Middle Aged; D044967:Serum; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult